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FDA approves Discovery's breathing disorder drug Surfaxin

Will be the first non animal-based treatment available for respiratory distress syndrome

The US Food and Drug Administration (FDA) has approved Discovery Laboratories' Surfaxin (lucinactant) to prevent a breathing disorder in infants.

The US regulator licensed it for the prevention of respiratory distress syndrome (RDS) – a condition that arises in premature infants who cannot make enough surfactant, a liquid that coats the inside of the lungs.

The lack of this coating, which helps the lungs to open, can lead to breathing difficulties and lung collapse.

Surfaxin, which Discovery expects to launch in the US in late 2012, is the first synthetically-created drug for the condition to be licensed in the US.

The existing four alternatives, including Abbott's Suvanta (beractant), Chiesi's Curosurf (poractant alpha) and Ony's Infasurf (calfactant) are all animal-based products.

Another product, Exosurf (colfosceril palmitate) developed by GlaxoSmithKline, is no longer marketed.

According to Discovery Labs, about 90,000 premature babies are treated for RDS each year with these animal-based surfactants.

“The approval of Surfaxin is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS,” said W Thomas Amic, chair and CEO of Discovery Labs.

The FDA's decision is based on a phase III clinical trial involving 1,294 premature infants. Within 30 minutes of birth, infants received either Surfaxin, Exosurf or Survanta, with Exosurf serving as the primary comparison in the study. Sufaxin demonstrating significant improvement in both RDS 24 hours after birth and RDS-related mortality over two weeks compared to Exosurf.

Side effects mainly related to the mechanism of use for the drug, with its administration involving an inserting an endotracheal tube into the infant.

The FDA had originally delayed its decision due to concerns over the drug's shelf life and manufacturing issues.

8th March 2012

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